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NCT06323161CompletedPhase 3

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes as Add on to Once-daily Basal Insulin With or Without Metformin

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
274 (actual)
First submitted
15 Mar 2024
Start date
26 Mar 2024
Primary completion date
9 Sept 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06323161
EU CT number
2022-502679-43-00
EudraCT number
2022-502679-43

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 274
  • From 26 Mar 2024 to the primary completion date, 9 Sept 2025
  • 61 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Lab values

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  • Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Who the study is looking for

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥180 days before screening.
  • On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening.
  • Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
  • Body Mass Index (BMI) greater than or equal to 25 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese People's Liberation Army General Hospital-Endocrinology
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BeijingChinaUnknown status
Jinan Central Hospital
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Ji'nanChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
Huaihe Hospital of Henan University
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KaifengChinaUnknown status
Huaihe Hospital of Henan University-Endocrinology
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KaifengChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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NanjingChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
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NanjingChinaUnknown status
Shanghai Pudong New Area People's Hospital-Endocrinology
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ShanghaiChinaUnknown status
The Affiliated Hospital of Jiangsu University-Endocrinology
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ZhenjiangChinaUnknown status
Kumanomae Nishimura Naika Clinic_Internal Medicine
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Arakawa-ku, TokyoJapanUnknown status
Akaicho Clinic
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Chiba-shi, ChibaJapanUnknown status
Kunisaki Makoto Clinic
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Fukuoka-shi, FukuokaJapanUnknown status
Futata Tetsuhiro Clinic Meinohama_Internal medicine
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Fukuoka-shi, FukuokaJapanUnknown status
Sasaki Internal Medicine
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HokkaidoJapanUnknown status
Naka Kinen Clinic_Internal medicine
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IbarakiJapanUnknown status
H.E.C Science Clinic
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KanagawaJapanUnknown status
H.E.C Science Clinic_Internal Medicine, Diabetes
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KanagawaJapanUnknown status
Kyoto University Hospital_Department of Diabetes, Endocr
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Kyoto-shi, KyotoJapanUnknown status
Minami Akatsuka Clinic_internal medicine
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Mito-shi, IbarakiJapanUnknown status
Manda Memorial Hospital_Internal Medicine
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Sapporo-shi, HokkaidoJapanUnknown status
Tokyo-Eki Center-building Clinic_Internal Medicine
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TokyoJapanUnknown status
Fukuwa Clinic_Internal Medicine
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TokyoJapanUnknown status
Tokyo-Eki Center-building Clinic
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TokyoJapanUnknown status
Kato Clinic of Internal Medicine_Internal Medicine
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TokyoJapanUnknown status
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
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Yamato-shiJapanUnknown status
Healthcare centre Zvezdara
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BelgradeSerbiaUnknown status
Healthcare centre Kragujevac
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KragujevacSerbiaUnknown status
Healthcare centre Nis
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NišSerbiaUnknown status
University Clinical Centre Nis
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NišSerbiaUnknown status
Policlinic for diabetes
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ZaječarSerbiaUnknown status
Dia Kontrol s.r.o.
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Kalna Nad HronomSlovakiaCompleted
MOMED, s.r.o
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Kráľovský ChlmecSlovakiaCompleted
SIN AZUCAR s.r.o.
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MalackySlovakiaCompleted
ENRIN, s.r.o.
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Rimavská SobotaSlovakiaCompleted
LUDIA, s. r. o.
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Spišská Nová VesSlovakiaCompleted
University of North Carolina
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Chapel HillUnited StatesUnknown status
Velocity Clinical Res-Dallas
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DallasUnited StatesUnknown status
Elite Research Center
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FlintUnited StatesUnknown status
Valley Research
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FresnoUnited StatesUnknown status
Synergy Groups Medical
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HoustonUnited StatesUnknown status
PlanIt Research, PLLC
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HoustonUnited StatesUnknown status
Holston Medical Group.
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KingsportUnited StatesUnknown status
Palm Research Center Inc
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Las VegasUnited StatesUnknown status
Manassas Clinical Research Center
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ManassasUnited StatesUnknown status
Solaris Clinical Research
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MeridianUnited StatesUnknown status
Bioclinical Research Alliance
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MiamiUnited StatesUnknown status
Clinical Research Associates
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NashvilleUnited StatesUnknown status
TPMG Clinical Research
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Newport NewsUnited StatesUnknown status
Alliance for Multispec Res
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NewtonUnited StatesUnknown status
Valley Clinical Trials, Inc.
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NorthridgeUnited StatesUnknown status
Endo and Metab Consultants
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RockvilleUnited StatesUnknown status
Simcare Medical Research, LLC
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Sugar LandUnited StatesUnknown status
Iowa Diab & Endo Res Center
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West Des MoinesUnited StatesUnknown status
Oraderumaz (Pty) Ltd
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BloemfonteinSouth AfricaUnknown status
Ashmed Medi-Centre
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Cape TownSouth AfricaUnknown status
Dr Vawda's site
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DurbanSouth AfricaUnknown status
Hemant Makan
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JohannesburgSouth AfricaUnknown status
Lenasia Clinical Trial Centre
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LenasiaSouth AfricaUnknown status
Prinshof Medical Campus
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PretoriaSouth AfricaUnknown status
Clinical Trial Systems (CTC)
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PretoriaSouth AfricaUnknown status
Dr Noeth's Practice
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PretoriaSouth AfricaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.